Mood DisorderNCT01270672
Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)
A study testing 3,4-Methylenedioxymethamphetamine and carvedilol in people with Mood Disorder and Substance-Related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder, Substance-Related Disorders, Amphetamine-Related Disorders
- What is being tested?
- 3,4-Methylenedioxymethamphetamine and carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sufficient understanding of the German language
- Subjects understand the procedures and the risks associated with the study
- Participants must be willing to adhere to the protocol and sign the consent form
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
- Participants must be willing not to drive a traffic vehicle in the evening of the study day.
- Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
- Body mass index: 18-25 kg/m2
Who cannot join
- Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
- Current or previous psychotic or affective disorder
- Psychotic or affective disorder in first-degree relatives
- Prior illicit drug use (except Tetrahydrocannabinol-containing products) more than 5 times or any time within the previous 2 months.
- Pregnant or nursing women.
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Pharmacology & Toxicology, University Hospital Basel
Basel, 4053
About this study
Official title: Effects of Carvedilol on the Cardiovascular and Subjective Response to MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy")
The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that carvedilol will attenuate the cardiovascular and subjective response to MDMA.
Read the detailed description
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine, and norepinephrine (NE). NE release is thought to mediate the cardiovascular effects of MDMA and may also contribute to its psychostimulant effects. However, the functional role of adrenergic postsynaptic receptors in the cardiovascular and subjective effects of MDMA in humans is largely unclear. To determine the role of alpha- and beta adrenergic receptors in the response to MDMA in humans the investigators test the effects of the alpha- and beta-receptor blocker carvedilol on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. Carvedilol or placebo will be administered 1 h before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that carvedilol will significantly reduce the blood pressure response to MDMA.
- Being tested
- 3,4-Methylenedioxymethamphetamine, carvedilol, placebo
- Keywords
- MDMA, carvedilol, norepinephrine, alpha - beta receptor, Ecstasy, stimulant
- Medical subject headings
- Mood Disorders, Substance-Related Disorders, Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3,4-MethylenedioxymethamphetamineDrug
Also called MDMA, Ecstasy, Adam
125 mg per os, single dose
carvedilolDrug
50 mg per os, single dose
placeboDrug
capsules identical to MDMA or carvedilol
| Study group | Role | What they receive |
|---|---|---|
| carvedilol, MDMA, placebo | Experimental | Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject. Receives: Drug: 3,4-Methylenedioxymethamphetamine; Drug: carvedilol; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of carvedilol on the blood pressure response to MDMA
Measured: 24 h
Secondary outcomes (3)
Effect of carvedilol on the subjective response to MDMA
Measured: 24 h
Effect of carvedilol on neuroendocrine effects of MDMA
Measured: 7 h
Effect of carvedilol on pharmacokinetics of MDMA
Measured: 7 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, MD, Principal investigator, Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270672
- Sponsor's protocol ID
- EK 218/10
- Status last verified
- Dec 2018
- First submitted
- 4 Jan 2011
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018.
PubMed 29912955Hysek CM, Liechti ME. Effects of MDMA alone and after pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin on pupillary light reflex. Psychopharmacology (Berl). 2012 Dec;224(3):363-76. doi: 10.1007/s00213-012-2761-6. Epub 2012 Jun 15.
PubMed 22700038
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carvedilol on the Cardiovascular and Subjective Response to MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy")
- ClinicalTrials.gov ID
- NCT01270672
- Acronym / sponsor ID
- EK 218/10
- Keywords
- MDMA, carvedilol, norepinephrine, alpha - beta receptor, Ecstasy, stimulant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determinate the effect of a pre-treatment with carvedilol, a alpha- and beta-adrenergic receptor blocker, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that carvedilol will attenuate the cardiovascular and subjective response to MDMA.
Detailed description
3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine, and norepinephrine (NE). NE release is thought to mediate the cardiovascular effects of MDMA and may also contribute to its psychostimulant effects. However, the functional role of adrenergic postsynaptic receptors in the cardiovascular and subjective effects of MDMA in humans is largely unclear. To determine the role of alpha- and beta adrenergic receptors in the response to MDMA in humans the investigators test the effects of the alpha- and beta-receptor blocker carvedilol on the physiological and subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. Carvedilol or placebo will be administered 1 h before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that carvedilol will significantly reduce the blood pressure response to MDMA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carvedilol, MDMA, placebo | Experimental | Drug: 3,4-Methylenedioxymethamphetamine, Drug: carvedilol, Drug: placeboCross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Sufficient understanding of the German language
- Subjects understand the procedures and the risks associated with the study
- Participants must be willing to adhere to the protocol and sign the consent form
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
Key exclusion criteria (7 listed)
- Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
- Current or previous psychotic or affective disorder
- Psychotic or affective disorder in first-degree relatives
- Prior illicit drug use (except Tetrahydrocannabinol-containing products) more than 5 times or any time within the previous 2 months.
- Pregnant or nursing women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3,4-MethylenedioxymethamphetamineAlso: MDMA, Ecstasy, Adam125 mg per os, single dose | Drug | carvedilol, MDMA, placebo |
| carvedilol50 mg per os, single dose | Drug | carvedilol, MDMA, placebo |
| placebocapsules identical to MDMA or carvedilol | Drug | carvedilol, MDMA, placebo |
Primary outcome
Effect of carvedilol on the blood pressure response to MDMA
Time frame: 24 h
3 secondary outcomes
Effect of carvedilol on the subjective response to MDMA
Time frame: 24 h
Effect of carvedilol on neuroendocrine effects of MDMA
Time frame: 7 h
Effect of carvedilol on pharmacokinetics of MDMA
Time frame: 7 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 29912955Vizeli P, Liechti ME. Oxytocin receptor gene variations and socio-emotional effects of MDMA: A pooled analysis of controlled studies in healthy subjects. PLoS One. 2018 Jun 18;13(6):e0199384. doi: 10.1371/journal.pone.0199384. eCollection 2018.
- Derived from this study: PubMed 22700038Hysek CM, Liechti ME. Effects of MDMA alone and after pretreatment with reboxetine, duloxetine, clonidine, carvedilol, and doxazosin on pupillary light reflex. Psychopharmacology (Berl). 2012 Dec;224(3):363-76. doi: 10.1007/s00213-012-2761-6. Epub 2012 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias E Liechti, MD principal investigator
Department of Internal Medicine, Division of Pharmacology & Toxicology, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3,4-Methylenedioxymethamphetamine and carvedilol in people with Mood Disorder and Substance-Related Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of carvedilol on the blood pressure response to MDMA (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270672, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.